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妊娠期妇女餐后脂代谢水平的研究
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注册号:

Registration number:

ChiCTR1800018884 

最近更新日期:

Date of Last Refreshed on:

2018-10-15 

注册时间:

Date of Registration:

2018-10-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

妊娠期妇女餐后脂代谢水平的研究 

Public title:

Study for postprandial lipid metabolism of pregnant women 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

妊娠期妇女餐后脂代谢水平的研究 

Scientific title:

Study for postprandial lipid metabolism of pregnant women 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

刘庆 

研究负责人:

张佳荣 

Applicant:

Liu Qing 

Study leader:

Zhang Jiarong 

申请注册联系人电话:

Applicant telephone:

+86 18101917515 

研究负责人电话:

Study leader's telephone:

+86 13361832527 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

18101917515@163.com 

研究负责人电子邮件:

Study leader's E-mail:

maggie1974@162.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

上海市松江区新松江路650号 

研究负责人通讯地址:

上海市松江区新松江路650号 

Applicant address:

650 Xinsongjiang Road, Songjiang District, Shanghai, China 

Study leader's address:

650 Xinsongjiang Road, Songjiang District, Shanghai, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

上海市第一人民医院 

Applicant's institution:

Shanghai General Hospital 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2018-26 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

上海市第一人民医院医学伦理委员会 

Name of the ethic committee:

Shanghai General Hospital Medical Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-06-20 

伦理委员会联系人:

耿雯倩 

Contact Name of the ethic committee:

Geng Wenqian 

伦理委员会联系地址:

上海市海宁路100号 

Contact Address of the ethic committee:

100 Haining Road, Shanghai, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

上海市第一人民医院 

Primary sponsor:

Shanghai General Hospital 

研究实施负责(组长)单位地址:

上海市松江区新松江路650号 

Primary sponsor's address:

650 Xinsongjiang Road, Songjiang, Shanghai, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市第一人民医院

具体地址:

上海市松江区新松江路650号

Institution
hospital:

Shanghai General Hospital

Address:

650 Xinsongjiang Road, Songjiang Shanghai

经费或物资来源:

上海交通大学医学院高峰高原计划 

Source(s) of funding:

Shanghai Jiaotong University School of Medicine Peak Plateau Program 

研究疾病:

妊娠期高甘油三脂血症 

Target disease:

Hypertriglyceridemia during pregnancy 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

评估不同脂耐量代谢水平与妊娠结局的关系 

Objectives of Study:

Assessing the relationship between different lipid tolerance levels and pregnancy outcomes 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

1:我院产检建卡的孕16W~24W单胎妊娠妇女,年龄21~40岁; 2:自愿参加本次研究并签署知情同意书 

Inclusion criteria

1. 16W~24W single-pregnant women pregnant in our hospital for birth check-up, aged 21~40 years old; 2. Voluntarily participate in this study and sign informed consent 

排除标准:

1)孕前患有糖尿病、高血压、肝肾功能异常等相关疾病史; 2)有胆石症、胆道感染、十二指肠降段疾病等病史; 3)空腹甘油三酯>5.6 mmol/L 4)患有严重贫血、严重感染、器质性心脏病、精神疾病、自身免疫等疾病; 

Exclusion criteria:

1) History of related diseases such as diabetes, hypertension, liver and kidney dysfunction before pregnancy; 2) Have a history of cholelithiasis, biliary tract infection, duodenal descending disease; 3) Fasting triglycerides >5.6 mmol/L 4) suffering from severe anemia, serious infection, organic heart disease, mental illness, autoimmune and other diseases. 

研究实施时间:

Study execute time:

From2018-10-22To 2019-06-30 

征募观察对象时间:

Recruiting time:

From2018-10-22To 2019-06-30 

干预措施:

Interventions:

组别:

不分组

样本量:

300

Group:

Case series

Sample size:

干预措施:

口服标准脂肪餐

干预措施代码:

Intervention:

Oral standard fat meal

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海市 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市第一人民医院 

单位级别:

三甲 

Institution
hospital:

Shanghai General Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

甘油三酯

指标类型:

主要指标 

Outcome:

Triglyceride

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胆固醇

指标类型:

主要指标 

Outcome:

cholesterol

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

游离脂肪酸

指标类型:

主要指标 

Outcome:

Free fatty acid

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

非随机

Randomization Procedure (please state who generates the random number sequence and by what method):

N/A

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

否No

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

原始数据保存于上海市第一人民医院产科,将在研究结果发表后一年内公开,可以通过E-mail、来访等查阅但不包括病人姓名等含有个人隐私的内容

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

The original data stored in the Department of Obstetrics, Shanghai General Hospital,, will open within one year after publication of the study, by E-mail,

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

原始记录表为病例观察表格,通过SPSS表格整理保存。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

The original record form is a case observation table, saved as SPSS table.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2018-10-15
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